None to declare. _n(">�"P��x�E,]��P��؁�����ȲX7�[M�w��Ȼ��\&X�%�R�VLj�Z3e��0m,jˌ ��V����uμS�!sg�a�ޠ� eN=�I���"`�&`�t��=�^�r��������L���)��$�`��h�V�sc��pk���D�K@�GCI��- �����,��?��؟|t��b���34?�ƣ�퀽���|�\Ԑ��L��O��/�Q!���߭'7�DŽ�֏��+����y����2 Medicinal Product Shortages. Drug Shortages Prevention Plan, Risk-Based Approach for Prevention and Management of Drug Shortages) to reduce the risk of medicine shortages occurring. In summary, views on how to tackle drug shortages vary a lot, but there is a broad consensus that pharmacists must have flexibility to mitigate shortages, with relevant controls in place. The Royal College of Ophthalmologists works with the UK Ophthalmic Pharmacy Group to update our members on drug shortages. Regulatory Agency (MHRA), the wider NHS, pharmaceutical companies, wholesalers and others in the supply chain to ensure consistency of supply of medicines. We’ll send you a link to a feedback form. We … The market is considered covered when supply is available from at least one manufacturer to cover total market demand. Pharmacists across the EU spent an extra hour each week dealing with medicines shortages in 2019, following an increase in the number of medicines shortages compared with 2018, a survey has found. Monitoring blood concentrations of clozapine (Clozaril, Denzapine, Zaponex) for toxicity is now advised in certain clinical situations. Capacity issues 3. Drug shortages are recognised as being an important global issue[1][1] that cause significant problems by delaying, and in some cases even preventing access to essential medicines. ����fF庞�8��?1L��� 3�/�i=�&�vi��0kD���f���KL9�?�rQ3�/?��_K~V-����-��f�2'R�:�c����*S'R�~���9V�X� The Clinigen Direct UK drug shortages platform is for the support of UK healthcare professionals only. A drug receives Resolved status when the Drug Shortages Staff (DSS) determines that the market is covered, based on information from all manufacturers. Declaration of interests. Notifying MHRA. EMA is acting as central coordinator in supporting Member States' activities in this area during the pandemic. Further changes came into force in July 2019, in the NHS (amendments relating to serious shortage protocols) Regulations 2019. For veterinary medicines, shortages are managed by the Department of Agriculture, Food and the Marine. Risk of meningioma with cyproterone acetate increases with increasing cumulative dose. These latter issues may overshadow any problems caused by Brexit. To keep pace with the health agency guidance related to the outbreak, it will be important to periodically check in with the applicable regulatory authorities for emerging guidance and any new announcements. The table Guidance has been published about thalidomide, lenalidomide, and pomalidomide and the use of remote consultations and home pregnancy testing for patients taking them during COVID-19. ). UK drug shortages list . h�bbd``b`�;��2�`Y��^J � $�bI�[� $|́D��psf`bd�d100���SO RFX Since the previous supply disruption alert update (SDA/2019/005-U) was issued on 27 November 2019, MHRA investigations have progressed as below. Medicine shortages during COVID-19 pandemic. 15 APR 2020 16:59 By Andrew Hill. Moreover, the solution requires collaboration and joint action. Parallel export of a medicine on the list is considered a breach of regulation 43(2) of the Human Medicines Regulations 2012 and a contravention of the wholesale dealer licence, and may lead to regulatory action by the Medicines and Healthcare products Regulatory Agency (MHRA) which could include immediate suspension of the wholesale dealer licence. Various drugs are in critically short supply. However, some manufacturers may not have all presentations available. Current drug shortages There are currently a number of UK wide drug shortages some with increases in cost. �H�i�8g��փ3Ү��ܒ�|�s���u8%-8�425�60dt0x0J0���(g ��" �110ld6aL`Hd���h�J��뼎��h��`z��=��Y�C�f��������H;0�����n�C���5�8�fg`Pe ���j/�~e�jƵ �K� Find drug safety updates issued by MHRA. Drugs in short supply often include sterile injectables and potentially life-saving oncology (cancer) treatments. Health officials reported the first U.S. drug shortage tied to the viral outbreak that is disrupting production in China, but they declined to identify the manufacturer or the product. Medicine shortages can occur for many reasons, such as manufacturing difficulties or problems affecting the quality of medicines that can impact on patient care.. The MHRA has classified phenytoin as a Category 1 antiepileptic drug, which means there are clear indications that clinically relevant differences between different manufacturers’ products might occur, even when the pharmaceutical forms are the same and … Guidance has been published to support initiation of valproate in female patients and for annual review and pregnancy testing during the coronavirus pandemic. Use baricitinib with caution in patients with diverticular disease and in those concomitantly treated with medications associated with an increased risk of diverticulitis. Alerts were issued about CME T34 and T34L (T60) ambulatory syringe pumps, Cardinal Health tympanic thermometers, t:slim X2 insulin pump, and Mavidon skin preparation electrode gels. MAHs are also expected to receive, analyse and react to any information from their manufacturers and suppliers that may cause supply disruption and lead to a shortage. Drug shortages can have a significant impact on patient care and public health. Excessive par… The Heads of Medicines Agencies have the task of informing the patients in cases of public concern or which affect the health care system. Contact patients currently taking Esmya for uterine fibroids as soon as possible and advise them to stop their treatment. However, medicine shortages are already widespread in the UK and the EU due to long-standing structural problems in the medicines supply chain. It will take only 2 minutes to fill in. Assurances that there are no issues would also be welcomed via the same email address. New recommendations following a review of the risks of dependence and addiction associated with prolonged use of opioid medicines (opioids) for non-cancer pain. SGLT2 inhibitor treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses and ketone levels measured, preferably in blood rather than urine. It provides a regularly updated, fully comprehensive UK drug shortage list and highlights the existing alternative available. In autoimmune conditions and some cancer therapies, methotrexate should be taken once a week; however, we continue to receive reports of inadvertent overdose due to more frequent dosing (including daily administration). Distribution and logistical problems 9. Tell us whether you accept cookies. Dwindling raw materials among other problems are causing several narcotics to not be produced in sufficient amounts. SSPs are the vehicle that has been created for this, but the consensus is that they need more scope to deliver better. There is an obligation for licence holders to notify the MHRA of any interruption in supply, for GMP matters this can be done via the Interim Compliance report which should be submitted to gmpinspectorate@mhra.gov.uk. Guidance has been published on monitoring of patients on warfarin and other anticoagulants during the COVID-19 pandemic. Accordingly, the ISPE Drug Shortages Task Team was formed to use the results of its 2013 Drug Shortages Survey [1] as a starting point to develop a framework that could be used by industry to develop strategies and practices for each of the six dimensions of the Plan. Cases of serotonin syndrome have been identified in associated with bupropion, especially in overdose or when bupropion is administered with other drugs with a serotonergic effect. Intervention in market mechanisms in the pricing of medicines and drug reimbursement 5. Update: EMA and its partners in the European Medicines Regulatory Network are putting measures in place to help prevent and mitigate possible disruptions to the supply of medicines in the European Union (EU) during the COVID-19 pandemic. Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency are at increased risk of severe and fatal toxicity during treatment with these medicines. advancing the interests of the drug … Ranitidine injection In the EU, most medicine shortages are dealt with at national level by national competent authorities. 0 We know that supply issues can occur due to a range of unforeseen events and may be down to a combination of factors including: 1. yf:N�&��A���5�d_�H�r�r"5�9��p,'R�?�����s��TljԄ�ȑ.�����r"5�_�4� ��\��4S�)$_�m�[��pS�C�MI��. Health agencies are actively working on assessing the impact of COVID-19 and the landscape is changing daily. By reviewing the content below you are confirming you are a UK healthcare professional. Ways to safeguard UK drug supplies during COVID-19 and beyond. The past few years have seen increasing concern about drug shortages. Please use the netFormulary FEEDBACK tab to ALERT the Medicines Optimisation Team to any potential CRITICAL DRUG ... On the 18th May 2020, the MHRA issued a class 2 recall to patient level for all unexpired batches of Emerade 500mcg auto-injectors. Earlier this year I posted the first part of 'Around the world in 80 ways' focussing on API supply chains. provide an opportunity to emphasize synergies between the EMA and the FDA. Drug shortages are a complex issue, which cannot be attributed to a single factor or manufacturer. Key MHRA advice and guidance issued so far on medicines safety and pharmacovigilance, including on reporting to the Yellow Card Scheme. Drug shortage is experience not only in the European region but also worldwide. The document ‘DHSC reporting requirements for medicine shortages and discontinuations’ replaces the best practice guidelines that were published in 2007. Drug recalls and quality issues 6. Here as promised is part 2. All content is available under the Open Government Licence v3.0, except where otherwise stated, Medicines and Healthcare products Regulatory Agency, Alerts and recalls for drugs and medical devices, Drug Safety Update: monthly PDF newsletter, Systemic and inhaled fluoroquinolones: small risk of heart valve regurgitation; consider other therapeutic options first in patients at risk, Erythromycin: caution required due to cardiac risks (QT interval prolongation); drug interaction with rivaroxaban, Erythromycin: update on known risk of infantile hypertrophic pyloric stenosis, Letters and drug alerts sent to healthcare professionals in November 2020, Modafinil (Provigil): increased risk of congenital malformations if used during pregnancy, Pirfenidone (Esbriet): risk of serious liver injury; updated advice on liver function testing, Ferric carboxymaltose (Ferinject▼): risk of symptomatic hypophosphataemia leading to osteomalacia and fractures, Bupropion (Zyban): risk of serotonin syndrome with use with other serotonergic drugs, Isotretinoin (Roaccutane▼): contribute to expert review, Letters and drug alerts sent to healthcare professionals in October 2020, 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity, Flucytosine (Ancotil): new contraindication in patients with DPD deficiency, Niraparib (Zejula▼): reports of severe hypertension and posterior reversible encephalopathy syndrome (PRES), particularly in early treatment, Dolutegravir (Tivicay▼, Triumeq▼, Juluca▼): updated advice on increased risk of neural tube defects, Warfarin and other anticoagulants: monitoring of patients during the COVID-19 pandemic, Every report counts: report suspected adverse drug reactions and take part in #MedSafetyWeek (2–8 November 2020), Letters and drug alerts sent to healthcare professionals in September 2020, Opioids: risk of dependence and addiction, Transdermal fentanyl patches for non-cancer pain: do not use in opioid-naive patients, Methotrexate once-weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing, Insulins (all types): risk of cutaneous amyloidosis at injection site, Letters and drug alerts sent to healthcare professionals in August 2020, Clozapine and other antipsychotics: monitoring blood concentrations for toxicity, Denosumab 60mg (Prolia): increased risk of multiple vertebral fractures after stopping or delaying ongoing treatment, Baricitinib (Olumiant▼): increased risk of diverticulitis, particularly in patients with risk factors, Isotretinoin (Roaccutane▼): reminder of important risks and precautions, Emollients and risk of severe and fatal burns: new resources available, Letters and drug alerts sent to healthcare professionals in July 2020, Medical Device Alerts issued in July 2020, Stimulant laxatives (bisacodyl, senna and sennosides, sodium picosulfate) available over-the-counter: new measures to support safe use, Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection, Liposomal and lipid-complex formulations: name change to reduce medication errors, Letters and drug alerts sent to healthcare professionals in June 2020, Medical Device Alerts issued in June 2020, Cyproterone acetate: new advice to minimise risk of meningioma, Direct-acting oral anticoagulants (DOACs): reminder of bleeding risk, including availability of reversal agents, Letters and drug alerts sent to healthcare professionals in May 2020, Coronavirus (COVID-19): new dedicated Yellow Card reporting site for medicines and medical devices, Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19), Immunomodulatory drugs and pregnancy prevention: temporary advice for management during coronavirus (COVID-19), Letters and drug alerts sent to healthcare professionals in April 2020, Coronavirus (COVID-19): latest guidance for medicines safety, Letters and drug alerts sent to healthcare professionals in March 2020, Esmya (ulipristal acetate): suspension of the licence due to risk of serious liver injury, Tofacitinib (Xeljanz▼): new measures to minimise risk of venous thromboembolism and of serious and fatal infections, Baricitinib (Olumiant▼): risk of venous thromboembolism, SGLT2 inhibitors: monitor ketones in blood during treatment interruption for surgical procedures or acute serious medical illness, Benzodiazepines and opioids: reminder of risk of potentially fatal respiratory depression, Letters and drug alerts sent to healthcare professionals in February 2020, Medical Device Alerts issued in February 2020, Coronavirus (COVID-19): guidance and support, Transparency and freedom of information releases, Therapeutic area: Haematology and 1 others, Therapeutic area: Infectious disease and 1 others, Therapeutic area: Anaesthesia and intensive care and 6 others, Therapeutic area: Respiratory disease and allergy, Therapeutic area: Pain management and palliation, Therapeutic area: Endocrinology, diabetology and metabolism, Therapeutic area: Cardiovascular disease and lipidology and 4 others, Therapeutic area: Endocrinology, diabetology and metabolism and 1 others, Therapeutic area: Dermatology and 1 others, Therapeutic area: GI, hepatology and pancreatic disorders and 1 others, Therapeutic area: Anaesthesia and intensive care and 3 others, Therapeutic area: Anaesthesia and intensive care and 2 others, Therapeutic area: Cardiovascular disease and lipidology and 1 others, Therapeutic area: Anaesthesia and intensive care and 8 others, Therapeutic area: Anaesthesia and intensive care and 17 others, Therapeutic area: Anaesthesia and intensive care and 7 others, Therapeutic area: Obstetrics, gynaecology and fertility, Therapeutic area: Haematology and 2 others, Therapeutic area: Anaesthesia and intensive care and 1 others, Therapeutic area: Pain management and palliation and 1 others, Therapeutic area: Anaesthesia and intensive care and 4 others. This is not intended as a guide to patients, who should always speak to their consultant, pharmacist or other medical professional about finding alternative medication. h޴�mo�6ǿ Don’t include personal or financial information like your National Insurance number or credit card details. products Regulatory Agency (MHRA), alongside European Health Authorities, has been investigating ranitidine products manufactured for the UK market. To help us improve GOV.UK, we’d like to know more about your visit today. We use cookies to collect information about how you use GOV.UK. We would like to bring to your attention some important communications and resources from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). A summary of letters and drug alerts recently sent to healthcare professionals, including recommendations to reduce handling errors with leuprorelin-containing depot medicines. The HPRA is responsible for co-ordinating the management of shortages of human medicines on the Irish market. Monitor serum phosphate levels in patients treated with multiple high-dose administrations, or those on long-term treatment, and in those with pre-existing risk factors for hypophosphataemia. Caution should be used in patients with known risk factors for venous thromboembolism in addition to the underlying disease. Benzodiazepines and opioids can both cause respiratory depression, which can be fatal if not recognised in time. You’ve accepted all cookies. endstream endobj startxref %%EOF We have introduced pack size restrictions, revised recommended ages for use, and new safety warnings for over-the-counter stimulant laxatives (orally and rectally administered) following a national safety review. We remind healthcare professionals that isotretinoin should only be used for severe forms of acne resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy. A fatal outcome certain clinical situations treated with medications associated with an increased risk of meningioma with cyproterone increases. Advised in certain mhra drug shortages situations Insurance number or credit Card details with a fatal outcome dealt at! Ingredient ( API ) shortages 7 to deliver better can be fatal if not recognised in time Clozaril. Female patients and for annual review and pregnancy testing during the Covid19 outbreak could! Site has been associated with an increased risk of meningioma with cyproterone acetate increases with increasing dose. With an increased risk of diverticulitis guidance issued so far on medicines safety and,! Injury has been investigating ranitidine products manufactured for the UK cases with a fatal outcome visit. 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